Effect of Intravenous FerRic carbOxymaltose oN Reverse Remodeling Following Cardiac Resynchronization Therapy

NCT03380520 | Completed Phase 4 DMC

• 1 other identifier: IRON-CRT
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

To assess impact on left ventricular reverse remodeling defined as a change in left ventricular ejection fraction in heart failure patients with reduced ejection fraction (and previous implantation of cardiac resynchronization therapy) undergoing treatment with ferric carboxymaltose vs. placebo

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Change in left ventricular ejection fraction from baseline

  delta\_LVEF measured by 3D-echocardiography

  3 months

Secondary Outcomes (5)

• Change in left ventricular end systolic volume from baseline

  3 months

• Change in left ventricular end diastolic volume from baseline

  3 months

• Force frequency relationship

  3 months

• Heart failure hospitalization and all-cause mortality

  Up to six months

• Incidence of Treatment-associated Serious and non-serious adverse events.

  During intravenous study drug administration and 1-hour in hospital follow-up

Other Outcomes (1)

• Predefined right ventricular (RV) analysis

  3 months

Study Arms (2)

Ferric carboxymaltose

EXPERIMENTAL

Ferric carboxymaltose according to SmPC

Drug: Ferric Carboxymaltose

Placebo

PLACEBO COMPARATOR

Normal saline (0.9%)

Drug: Placebo

Interventions

Ferric Carboxymaltose DRUG

Ferric carboxymaltose will be administered according to product specification dosing

Also known as: injectafer

Ferric carboxymaltose

Placebo DRUG

IV nacl 0.9%

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic heart failure and implantation of cardiac resynchronization therapy more than 6 months ago and presence of iron deficiency (ferritin \< 100 μg/l, irrespective of TSAT or ferritine between 100 - 300 μg/l with TSAT \< 20%) and presence of incomplete reverse remodeling (LVEF \< 40%).
• Age ≥18 years
• Obtained informed consent
• Stable pharmacological therapy of heart failure during the last 4 weeks (with the exception of diuretics)

You may not qualify if:

• Hemochromatosis, iron overload, defined as TSAT \> 45%
• Known hypersensitivity to injectafer®.
• Known active infection, CRP\>20 mg/L, clinically significant bleeding, active malignancy.
• Chronic liver disease and/or screening alanine transaminase (ALT) or aspartate transaminase (AST) above three times the upper limit of the normal range.
• Immunosuppressive therapy or renal dialysis (current or planned within the next 6 months).
• History of erythropoietin, i. v. or oral iron therapy, and blood transfusion in previous 12 weeks and/or such therapy planned within the next 6 months.
• Unstable angina pectoris as judged by the investigator, clinically significant uncorrected valvular disease or left ventricular outflow obstruction, obstructive cardiomyopathy, poorly controlled fast atrial fibrillation or flutter, poorly controlled symptomatic brady- or tachyarrhythmias.
• Acute myocardial infarction or acute coronary syndrome, transient ischemic attack or stroke within the last 3 months.
• Coronary-artery bypass graft, percutaneous intervention (e.g. cardiac, cerebrovascular, aortic; diagnostic catheters are allowed) or major surgery, including thoracic and cardiac surgery, within the last 3 months.
• Inability to fully comprehend and/or perform study procedures in the investigator's opinion.
• Vitamin B12 and/or serum folate deficiency according to the laboratory (re-screening is possible after substitution therapy).
• Pregnancy or lactation.
• Participation in another clinical trial within previous 30 days and/or anticipated participation in another trial during this study.
• Planned cardiac hospitalization during study follow-up

Sponsors & Collaborators

• Hasselt University: lead
• Ziekenhuis Oost-Limburg: collaborator

Study Sites (1)

Pieter Martens

Genk, Limburg, 3500, Belgium

Location

Related Publications (1)

• Martens P, Dupont M, Dauw J, Nijst P, Herbots L, Dendale P, Vandervoort P, Bruckers L, Tang WHW, Mullens W. The effect of intravenous ferric carboxymaltose on cardiac reverse remodelling following cardiac resynchronization therapy-the IRON-CRT trial. Eur Heart J. 2021 Dec 21;42(48):4905-4914. doi: 10.1093/eurheartj/ehab411.

  PMID: 34185066 RESULT

MeSH Terms

Conditions

Heart Failure

Interventions

ferric carboxymaltose

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Md PhD

Study Record Dates

• First Submitted: November 2, 2017
• First Posted: December 21, 2017
• Study Start: October 1, 2017
• Primary Completion: December 31, 2020
• Study Completion: August 4, 2021
• Last Updated: August 11, 2021

Record last verified: 2021-08

Locations

BE (1)